Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-9899 |
Trade Name | Dose Form | Strength | Identifier |
Macrobid | Modified release capsule | 100 mg | |
Sponsor | Application date | Registration situation | Classification |
Te Arai BioFarma Limited P O Box 46-205 Herne Bay Auckland 1147 | 8/12/2015 | Consent given Approval date: 1/10/2020 | Prescription |
Composition
Component | Ingredient | Manufacturer |
modified release capsule | Active | |
Nitrofurantoin 25mg (macrocrystals) | F.I.S. Fabbrica Italiana Sintetici SpA Viale Milano 26 Montecchio Maggiore Vicenza 36075 ITALY | |
Nitrofurantoin monohydrate 80.7mg | F.I.S. Fabbrica Italiana Sintetici SpA Viale Milano 26 Montecchio Maggiore Vicenza 36075 ITALY | |
Excipient | ||
Carbomer 934P | ||
Gelatin | ||
Lactose monohydrate | ||
Magnesium stearate | ||
Maize starch | ||
Povidone | ||
Purified talc | ||
Sucrose |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Norwich Pharmaceuticals Inc 6826 State Highway 12 North Norwich New York 13815 UNITED STATES OF AMERICA |
Manufacture of Final Dose Form | Norwich Pharmaceuticals Inc 6826 State Highway 12 North Norwich New York 13815 UNITED STATES OF AMERICA |
Packing | Norwich Pharmaceuticals Inc 6826 State Highway 12 North Norwich New York 13815 UNITED STATES OF AMERICA |
NZ Site of Product Release | Te Arai BioFarma Limited 91 Red Hill Rd Te Arai Wellsford 0974 |
Packaging
Package | Contents | Shelf Life |
Bottle, plastic, 150cc HDPE bottle with CRC cap | 100 capsules | 24 months from date of manufacture stored at or below 25°C |
Indications
Macrobid is indicated for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Therapy with nitrofurantoin may be initiated before results of culture and susceptibility tests are known; therapy should be continued or altered, as appropriate, in accordance with results of the tests.
Macrobid is indicated for the prophylaxis of urinary tract infections after surgery or procedures involving genitourinary tract.
Macrobid is not indicated for the treatment of pyelonephritis or peri-nephric abscesses.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
11/5/2023 | Changed Medicine Notification | Finished product specifications/test methods - G2 | Granted 14/6/2023 | 17/5/2023 | |
8/12/2015 | New Higher-risk Medicine Application | New higher-risk medicine that does not contain a new active substance | Granted 1/10/2020 | 15/12/2015 |